Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury
6 de enero de 2022 actualizado por: Dorothy Barthélemy, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training
The objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
After obtaining their consent, participants will undertake evaluations at different times:
- Assessment 1 week prior to training
- Training over 4 weeks (nature of the training depends on the group)
- Assessment 1 week after training
- Assessment 1 month after training (follow-up)
Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. Days can be consecutive or non-consecutive but will be within a given week. The assessment consists of:
- Session 1 (S1; duration: 3h) will include presentation of the Study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment.
- Session 2 (S2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of H reflex.
After the initial assessment, iSCI participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. The training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
36
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Dorothy Barthélemy, PhD, PT
- Número de teléfono: 514-343-7712
- Correo electrónico: dorothy.barthelemy@umontreal.ca
Ubicaciones de estudio
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Quebec
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Montréal, Quebec, Canadá
- Reclutamiento
- Neuromobility lab
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Contacto:
- Dorothy Barthélemy, PhD, PT
- Número de teléfono: 514-343-7712
- Correo electrónico: dorothy.barthelemy@umontreal.ca
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
FOR PARTICIPANTS WITH SPINAL CORD INJURY
Inclusion Criteria:
- Have an incomplete lesion of spinal cord
- Level of spinal cord lesion between C5 and T12
- At least, 6 months post-injury
- Be considered as AIS C or D
- Be able to stand without support for 15 seconds
- Be able to provide informed consent in English or in French
Exclusion Criteria:
- To have cognitive deficits
- To have personal or family history of epilepsy
- To have suffered moderate or severe traumatic brain injury
- To have cochlear implant
FOR CONTROL PARTICIPANTS
Exclusion Criteria:
- To have orthopedics problems
- To have cognitive deficits
- To have neurological problems
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Combined explosive strength and specific balance training group
This group will be formed with participants with incomplete spinal cord injury.
This group will perform 4 weeks of combined explosive strength and specific balance training.
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Training will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations. Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements. Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions:
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Sin intervención: Spinal cord injury control group
This group will be formed with participants with incomplete spinal cord injury.
They will perform all the evaluation before and after a 4-week period of rest (no training).
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Sin intervención: Healthy control group
Healthy participants will be recruited based on the age and sex of the participants with incomplete spinal cord injury to realize clinical and neurophysiological cortical evaluations.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in muscles EMG responses following balance perturbation
Periodo de tiempo: Pre-intervention, immediately after and one-month after intervention
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Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
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Pre-intervention, immediately after and one-month after intervention
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Change in center of pressure displacement following balance perturbation using a force platform
Periodo de tiempo: Pre-intervention, immediately after and one-month after intervention
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Excursion of centre of pressure will be analyzed following forward and backward perturbation.
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Pre-intervention, immediately after and one-month after intervention
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Change in ankle muscle strength using force transducer
Periodo de tiempo: Pre-intervention, immediately after and one-month after intervention
|
Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.
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Pre-intervention, immediately after and one-month after intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
Periodo de tiempo: Pre-intervention, immediately after and one-month after intervention
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A paired-pulses paradigm (two trans cranial magnetic stimulations at motor cortex level) will be used to evaluate the intracortical mechanisms
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Pre-intervention, immediately after and one-month after intervention
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Change in the influence of peripheral afferents on cortical output using short-afference inhibition
Periodo de tiempo: Pre-intervention, immediately after and one-month after intervention
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A stimulation (using TMS) at motor cortex level will be triggered just after a peripheral electrical stimulation of tibial nerve to evaluate the peripheral afferents on cortical output.
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Pre-intervention, immediately after and one-month after intervention
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Change in the modulation of the H reflex by the corticospinal tract
Periodo de tiempo: Pre-intervention, immediately after and one-month after intervention
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A stimulation (using TMS) at motor cortex level will be triggered just before a tibial nerve stimulation to evaluate the modulation of the H reflex by the corticospinal tract.
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Pre-intervention, immediately after and one-month after intervention
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Change in EMG responses following vestibular stimulations during quiet standing
Periodo de tiempo: Pre-intervention, immediately after and one-month after intervention
|
Galvanic vestibular stimulation will be triggered during quiet standing.
EMG responses of Soleus and Tibialis Anterior muscles will be analyzed.
|
Pre-intervention, immediately after and one-month after intervention
|
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Change in the excursion of the center of pressure following vestibular stimulations
Periodo de tiempo: Pre-intervention, immediately after and one-month after intervention
|
Galvanic vestibular stimulation will be triggered during quiet standing.
The displacement of the center of pressure will be analyzed using a force platform.
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Pre-intervention, immediately after and one-month after intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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MOntreal Cognitive Assessment (MoCA) score
Periodo de tiempo: Before enrollment
|
The maximal score is 30 and minimal score 0.
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Before enrollment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de julio de 2018
Finalización primaria (Anticipado)
1 de diciembre de 2022
Finalización del estudio (Anticipado)
1 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
1 de septiembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
6 de enero de 2022
Publicado por primera vez (Actual)
20 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de enero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
6 de enero de 2022
Última verificación
1 de enero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRIR 1325-0118
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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